Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

Amiodarone Injection: Administer 300 mg of intravenous amiodarone as a loading dose once daily (QD) and 200 mg of oral amiodarone twice daily (BID) within 24 hours postoperatively, and continue for 3 consecutive days.

Sodium Chloride Injection 0.9%: Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.

Study summary

This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \[SR\], long-term recurrence \[LR\], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.

Eligibility

Primary outcome measure(s)

• Recurrence of atrial arrhythmia lasting more than 30 seconds. — At least 12 months of follow-up, beyond the initial 3 month blanking period
  After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - occurring beyond the initial 3-month blanking period.

Trial sites (1)

More Shanghai Chest Hospital trials in China

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